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Brief Title: A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
Official Title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma
Study ID: NCT05002569
Brief Summary: The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
Detailed Description:
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Local Institution - 0176, Birmingham, Alabama, United States
Local Institution - 0164, Springdale, Arkansas, United States
Local Institution - 0200, Los Angeles, California, United States
Local Institution - 0185, Palo Alto, California, United States
Local Institution - 0162, San Francisco, California, United States
Local Institution - 0138, Aurora, Colorado, United States
Local Institution - 0166, Washington, District of Columbia, United States
Local Institution - 0243, Miami, Florida, United States
Local Institution, Miami, Florida, United States
Local Institution - 0179, Pensacola, Florida, United States
Local Institution - 0191, Atlanta, Georgia, United States
Local Institution - 0148, Atlanta, Georgia, United States
Local Institution - 0202, Chicago, Illinois, United States
Local Institution - 0177, Peoria, Illinois, United States
Local Institution - 0223, Fort Wayne, Indiana, United States
University of Iowa-Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Local Institution - 0178, Westwood, Kansas, United States
Local Institution - 0258, Ann Arbor, Michigan, United States
Local Institution, Grand Rapids, Michigan, United States
Local Institution - 0133, Minneapolis, Minnesota, United States
Local Institution - 0139, Hackensack, New Jersey, United States
Local Institution - 0206, Morristown, New Jersey, United States
Local Institution - 0140, New York, New York, United States
Local Institution - 0210, New York, New York, United States
Local Institution - 0130, Charlotte, North Carolina, United States
Local Institution - 0145, Durham, North Carolina, United States
Local Institution - 0141, Cleveland, Ohio, United States
Local Institution - 0267, Allentown, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Local Institution - 0125, Pittsburgh, Pennsylvania, United States
Local Institution - 0171, Charleston, South Carolina, United States
Local Institution - 0147, Germantown, Tennessee, United States
Local Institution - 0183, Nashville, Tennessee, United States
Local Institution - 0146, Austin, Texas, United States
Local Institution - 0163, Dallas, Texas, United States
Local Institution - 0172, Houston, Texas, United States
Local Institution - 0137, Fairfax, Virginia, United States
Clinica Adventista Belgrano-Oncology, Caba, Distrito Federal, Argentina
Local Institution - 0005, Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina
Local Institution - 0002, Ciudad de Buenos Aires, Distrito Federal, Argentina
Local Institution - 0003, Buenos Aires, , Argentina
Local Institution - 0004, Cordoba, , Argentina
Local Institution - 0030, Waratah, New South Wales, Australia
Local Institution - 0252, Westmead, New South Wales, Australia
Local Institution - 0032, Wollstonecraft, New South Wales, Australia
Local Institution - 0028, Brisbane, Queensland, Australia
Local Institution - 0027, Southport, Queensland, Australia
Local Institution - 0250, Woodville, South Australia, Australia
Local Institution, Ballarat Central, Victoria, Australia
Local Institution - 0035, Ballarat, Victoria, Australia
Local Institution - 0253, Heidelberg, Victoria, Australia
Local Institution - 0031, Melbourne, Victoria, Australia
Local Institution - 0251, Murdoch, Western Australia, Australia
Local Institution - 0029, Perth, Western Australia, Australia
Local Institution - 0082, Graz, Steiermark, Austria
Local Institution - 0086, Salzburg, , Austria
Local Institution - 0084, Vienna, , Austria
Local Institution - 0110, Brussels, , Belgium
Local Institution - 0105, Bruxelles, , Belgium
Local Institution - 0109, Liège, , Belgium
Local Institution - 0106, Wilrijk, , Belgium
Local Institution - 0071, Salvador, Bahia, Brazil
Local Institution - 0072, Fortaleza, Ceara, Brazil
Local Institution - 0068, Vitória, Espirito Santo, Brazil
Local Institution - 0047, Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0056, Ijui, Rio Grande Do Sul, Brazil
Local Institution - 0257, Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0049, Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0048, Santa Cruz do Sul, RIO Grande DO SUL, Brazil
Local Institution - 0070, Barretos, SAO Paulo, Brazil
Local Institution - 0058, Rio de Janeiro, , Brazil
Local Institution - 0155, Edmonton, Alberta, Canada
Local Institution - 0175, Vancouver, British Columbia, Canada
Local Institution - 0197, Halifax, Nova Scotia, Canada
Local Institution - 0158, Montreal, Quebec, Canada
Local Institution - 0159, Montréal, Quebec, Canada
Local Institution - 0160, Quebec City, Quebec, Canada
Local Institution - 0198, Sherbrooke, Quebec, Canada
Local Institution - 0013, Santiago, Metropolitana, Chile
Local Institution - 0006, Santiago, Metropolitana, Chile
Local Institution - 0014, Santiago, Metropolitana, Chile
Local Institution - 0259, Beijing, Beijing, China
Local Institution - 0261, Beijing, Beijing, China
Local Institution - 0214, Beijing, Beijing, China
Local Institution - 0241, Chongqing, Chongqing, China
Local Institution - 0245, Fuzhou City, Fujian, China
Local Institution - 0217, Guangzhou, Guangdong, China
Local Institution - 0226, Zhengzhou Shi, Henan, China
Local Institution - 0237, Wuhan, Hubei, China
Local Institution - 0239, Wuhan, Hubei, China
Local Institution - 0234, Changsha Shi, Hunan, China
Local Institution - 0215, Nanjing, Jiangsu, China
Local Institution - 0224, Nanchang, Jiangxi, China
Local Institution - 0219, Changchun, Jilin, China
Local Institution - 0242, Shenyang, Liaoning, China
Local Institution - 0230, Chengdu, Sichuan, China
Local Institution, Tianjin, Tianjin, China
Local Institution - 0228, Urumqi, Xinjiang, China
Local Institution - 0222, Kunming, Yunnan, China
Local Institution - 0216, Hangzhou, Zhejiang, China
Local Institution - 0244, Taiyuan, , China
Local Institution - 0156, Brno, , Czechia
Local Institution - 0091, Hradec Kralove, , Czechia
Local Institution - 0026, Ostrava, , Czechia
Local Institution - 0062, Prague, , Czechia
Local Institution - 0022, Aalborg, , Denmark
Local Institution - 0018, Copenhagen, , Denmark
Local Institution - 0020, Odense, , Denmark
Local Institution - 0007, Helsinki, , Finland
Local Institution - 0019, Tampere, , Finland
Local Institution - 0015, Turku, , Finland
Local Institution - 0040, Villejuif, Val-de-Marne, France
Local Institution - 0043, Dijon, , France
Local Institution - 0044, Marseille, , France
Local Institution - 0039, Nantes, , France
Local Institution - 0042, Paris, , France
Local Institution - 0041, Pierre-Bénite, , France
Local Institution - 0046, Toulouse, , France
Local Institution - 0092, Tübingen, Baden-Württemberg, Germany
Local Institution - 0079, Hannover, Lower Saxony, Germany
Local Institution - 0073, Buxtehude, , Germany
Local Institution - 0077, Dresden, , Germany
Local Institution - 0074, Erlangen, , Germany
Local Institution - 0131, Essen, , Germany
Local Institution - 0081, Gera, , Germany
Local Institution - 0075, Heidelberg, , Germany
Local Institution - 0078, Lübeck, , Germany
Local Institution - 0083, Minden, , Germany
Local Institution - 0076, Munich, , Germany
Local Institution - 0080, Wuerzburg, , Germany
Local Institution - 0114, Athens, , Greece
Local Institution - 0113, Neo Faliro, , Greece
Local Institution - 0112, Thessaloniki, , Greece
Local Institution - 0118, Jerusalem, Yerushalayim, Israel
Local Institution - 0116, Afula, , Israel
Local Institution - 0199, Ramag Gan, , Israel
Local Institution - 0117, Ramat Gan, , Israel
Istituto Europeo di Oncologia IRCCS, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie, Napoli, , Italy
Istituto Oncologico Veneto IRCCS-Oncologia del Melenoma, Padova, , Italy
Azienda Ospedaliera Di Perugia, Perugia, , Italy
ospedale le scotte-U.O.C. Immunoterapia Oncologica, Siena, , Italy
Local Institution - 0100, Benito Juarez, Distrito Federal, Mexico
Local Institution - 0021, Zapopan, Jalisco, Mexico
Local Institution - 0093, Mexico, Nuevo LEON, Mexico
Local Institution - 0098, Oaxaca, , Mexico
Local Institution - 0009, Lørenskog, Akershus, Norway
Local Institution - 0017, Oslo, , Norway
Local Institution - 0023, Stavanger, , Norway
Local Institution - 0170, Brasov, , Romania
Local Institution - 0065, Cluj, , Romania
Local Institution - 0066, Craiova, , Romania
Local Institution - 0064, Floresti/ Cluj, , Romania
Local Institution - 0188, Badajoz, , Spain
Local Institution - 0201, Barcelona, , Spain
Local Institution - 0153, Granada, , Spain
Local Institution - 0150, Madrid, , Spain
Local Institution - 0151, San Sebastian, , Spain
Local Institution - 0152, València, , Spain
Local Institution - 0010, Gothenburg, , Sweden
Local Institution - 0011, Lund, , Sweden
Local Institution - 0012, Solna, , Sweden
Local Institution - 0085, Basel, , Switzerland
Local Institution - 0087, Chur, , Switzerland
Local Institution - 0090, Zürich, , Switzerland
Local Institution - 0187, Glasgow, Lanarkshire, United Kingdom
Local Institution - 0101, Nottingham, Nottinghamshire, United Kingdom
Local Institution - 0102, Bristol, , United Kingdom
Local Institution - 0154, Newcastle upon Tyne, , United Kingdom
Local Institution - 0232, Oxford, , United Kingdom
Local Institution - 0127, Southampton, , United Kingdom
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR